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Zimmer Manufacturing B.V. recalls Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, a
Recalled July 16, 2014 · FDA recall Z-2032-2014 · Zimmer Manufacturing B.V
Hazard
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14. · FDA Class II
Units
496
Sold at
Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
Description
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
Product
Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
Manufacturer(s)
Zimmer Manufacturing B.V.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →